South Berwick Pharmacy Seacoast Compounding, Inc.
Form 483 issued September 30, 2022 · South Berwick, Maine
- Inspection
- Sep 12 – Sep 30, 2022
- Investigators
- Daniel L. Zheng· Erik W. Koester
- Observations
- 4
- Pages
- 4
- FEI number
- 3005636572
In short: On September 30, 2022, FDA issued a Form 483 with 4 observations to South Berwick Pharmacy Seacoast Compounding, Inc. in South Berwick, Maine (FEI 3005636572) after an inspection that ran Sep 12 – Sep 30, 2022. The investigators were Daniel L. Zheng and Erik W. Koester.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You produced hazardous drug; without providing adequate containment, segregation, cleaning of work surfaces and cleaning of…
- 02FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 03FDCA 501(a)(2)(A)
Vermin was observed in…
- 04FDCA 501(a)(2)(A)
You used a non-pharmaceutical grade component in the formulation…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSouth Berwick Pharmacy Seacoast Compounding, Inc. history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at South Berwick Pharmacy Seacoast Compounding, Inc.?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected South Berwick Pharmacy Seacoast Compounding, Inc.?
Daniel L. Zheng and Erik W. Koester are named on this Form 483, for the inspection of Sep 12 – Sep 30, 2022. Each investigator has a profile showing what they cite most.
When was South Berwick Pharmacy Seacoast Compounding, Inc. inspected by FDA?
The inspection ran Sep 12 – Sep 30, 2022, and the Form 483 is dated September 30, 2022.
How do I get the full Form 483 for South Berwick Pharmacy Seacoast Compounding, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.