Boothwyn Pharmacy LLC
FDA inspection history in Kennett Square, Pennsylvania, 2017 to 2026
- 5
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2017: one Form 483; 2018: one close-out letter; 2021: one Form 483; 2023: one Form 483; 2024: one Form 483; 2025: one warning letter and one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18One Form 483 and one close-out letter, at Kennett Square, Pennsylvania.
- 2017The longest 483 on file: 10 observations over 4 pages at Kennett Square, Pennsylvania.
- 2021–26Four Form 483s and two warning letters, at Kennett Square, Pennsylvania.
Cited most
Across all Boothwyn Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination13
- 21 CFR 211.42Design and construction features6
- FDCA 501(a)(2)(A)Insanitary conditions5
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
The complete Boothwyn Pharmacy file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Kennett Square, Pennsylvania
Five Form 483s, two warning letters and one close-out letter · 2017 to 2026 · 35 observations
Latest: Warning letter, Jan 16, 2026 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-01-16 | Warning letter Warning letter | Kennett Square, Pennsylvania | — | $99 |
| 2025-06-09 | Warning letter Warning letter | Kennett Square, Pennsylvania | — | $99 |
| 2025-06-09 | 483 Form 483 | Kennett Square, Pennsylvania | 6 | $99 |
| 2024-10-22 | 483 Form 483 | Kennett Square, Pennsylvania | 5 | $99 |
| 2023-08-29 | 483 Form 483 | Kennett Square, Pennsylvania | 5 | $99 |
| 2021-09-08 | 483 Form 483 | Kennett Square, Pennsylvania | 9 | $99 |
| 2018-07-25 | Close-out Close-out letter | Kennett Square, Pennsylvania | — | $99 |
| 2017-06-16 | 483 Form 483 | Kennett Square, Pennsylvania | 10 | $99 |
Investigators on these documents
Christina K. Theodorou (3)Evan Tong (1)Juanita P. Versace (1)Julia N. Alvarez (1)Mindy M. Chou (1)Rahi D. Patel (1)Sena G. Dissmeyer (1)Tanya R. Syffrard (1)
FEI number 1000076625 · most recent document Jan 16, 2026
About Boothwyn Pharmacy LLC
How many FDA Form 483s has Boothwyn Pharmacy LLC received?
FDA Intel has 5 Form 483s on file for Boothwyn Pharmacy LLC; the most recent is dated Jun 9, 2025.
When was Boothwyn Pharmacy LLC last inspected by FDA?
The most recent FDA inspection document on file for Boothwyn Pharmacy LLC is a Form 483 dated Jun 9, 2025, for the site in Kennett Square, Pennsylvania.
What did FDA cite at Boothwyn Pharmacy LLC?
The regulations cited most in the observations on file for Boothwyn Pharmacy LLC are 21 CFR 211.113 (Control of microbiological contamination), 13 times; 21 CFR 211.42 (Design and construction features), 6 times; FDCA 501(a)(2)(A) (Insanitary conditions), 5 times.
Has Boothwyn Pharmacy LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Boothwyn Pharmacy LLC; the most recent is dated Jan 16, 2026.