Zhejiang Huahai Pharmaceutical Co., Ltd.
This drug manufacturing facility is registered with the FDA by Zhejiang Huahai Pharmaceutical Co., Ltd.. ProPublica was able to identify at least 225 generic drugs that have been manufactured at this facility.
Facility Inspection History
The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.
Note: ProPublica does not provide medical advice. Stopping your medication, doctors warn, can be dangerous. Please consult your doctor first if you have concerns. Read more
7
Known Inspections
The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.
3
Inspections Found Issues
When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.
- Jun 6, 2025Jun 6, 2025Warning Letter
The FDA issued a warning letter laying out significant issues.
The letter is a disciplinary tool the FDA uses to lay out significant violations of manufacturing standards and to outline needed improvements. It often includes a summary of the steps the company had initially pledged to take to correct issues identified during inspections. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public. - Jan 24, 2025Jan 24, 2025Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jul 2, 2021Jul 2, 2021Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Jun 28, 2019Jun 28, 2019
An inspector documented issues at the facility.
We were unable to connect this 483 form to an FDA inspection designation, but we do know that an inspector filed this form observing problem(s).View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - May 31, 2019May 31, 2019Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Nov 18, 2016Nov 18, 2016Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 27, 2015Mar 27, 2015Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Aug 9, 2013Aug 9, 2013Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Sep 2, 2010Sep 2, 2010Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
Drugs Manufactured Here
Below is a list of generic prescription drugs that we’ve been able to connect to this facility. Brand name and over-the-counter drugs, as well as labels we were unable to trace, are not included here.
CompanySolco Healthcare U.s
Dosage
2mg
Off-white capsule-shaped tablet marked with 2 P
NDC: 43547-302-X
CompanySolco Healthcare U.s
Dosage
5mg
Pink capsule-shaped tablet marked with 5 P
NDC: 43547-303-X
CompanySolco Healthcare U.s
Dosage
15mg
Pink round tablet marked with 15 P
NDC: 43547-305-X
CompanySolco Healthcare U.s
Dosage
20mg
Brown (beige) round tablet marked with 20 P
NDC: 43547-306-X
CompanySolco Healthcare U.s
Dosage
30mg
Off white round tablet marked with 30 P
NDC: 43547-307-X
CompanyA-s Medication Solutions
Dosage
2mg
Off-white capsule-shaped tablet marked with 2 P
NDC: 50090-7105-0
CompanySolco Healthcare U.s
Dosage
10mg
Brown (beige) capsule-shaped tablet marked with 10 P
NDC: 43547-304-X
CompanySt. Mary's Medical Park Pharmacy
Dosage
10mg
Red round tablet, coated marked with S 342
NDC: 60760-351-90
CompanySt. Mary's Medical Park Pharmacy
Dosage
20mg
Gray round tablet, coated marked with S 343
NDC: 60760-352-90
CompanySonoma Pharmaceuticals
Dosage
150mg
White capsule-shaped tablet, delayed release marked with P 0 1
NDC: 69668-515-30
CompanySolco Healthcare Us
Dosage
50mg
White oval tablet, delayed release marked with P03
NDC: 43547-462-12
CompanySolco Healthcare Us
Dosage
200mg
White oval tablet, delayed release marked with P0 02
NDC: 43547-325-X
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