Hybrid Pharma LLC
FDA inspection history across 2 sites, 2016 to 2024
- 4
- Form 483s
- 1
- Response
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Response
- Form 483
- Warning letter
- Close-out
2016: one Form 483; 2018: one close-out letter; 2019: one amended 483; 2021: one Form 483; 2022: one warning letter; 2023: one Form 483; 2024: one 483 response.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–24Three Form 483s, one close-out letter, one amended 483, one warning letter and one 483 response, at Deerfield Beach, Florida and Florida.
- 2023The longest 483 on file: 11 observations over 11 pages at Deerfield Beach, Florida.
Cited most
Across all Hybrid Pharma observations on file
- 21 CFR 211.42(c)(10)(i)Design and construction features10
- 21 CFR 211.165(a)Testing and release for distribution4
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.192Production record review2
The complete Hybrid Pharma file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Deerfield Beach, Florida
Three Form 483s, one warning letter, one amended 483 and one close-out letter · 2016 to 2023 · 38 observations
Latest: Form 483, Nov 9, 2023 →Florida
One 483 response · 2024
Latest: Response, Jan 31, 2024 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-31 | Response 483 response | Florida | — | $199 |
| 2023-11-09 | 483 Form 483 | Deerfield Beach, Florida | 11 | $99 |
| 2022-06-07 | Warning letter Warning letter | Deerfield Beach, Florida | — | $99 |
| 2021-09-03 | 483 Form 483 | Deerfield Beach, Florida | 7 | $99 |
| 2019-06-20 | Amended 483 Amended 483 | Deerfield Beach, Florida | 11 | $99 |
| 2018-11-30 | Close-out Close-out letter | Deerfield Beach, Florida | — | $99 |
| 2016-07-28 | 483 Form 483 | Deerfield Beach, Florida | 9 | $99 |
Investigators on these documents
Bonita S. Chester (1)Jennifer Lalama (1)Joanne E. King (1)Latorie S. Jones (1)Stephanie D. Crockett (1)
FEI number 3011319445 · most recent document Jan 31, 2024
About Hybrid Pharma LLC
How many FDA Form 483s has Hybrid Pharma LLC received?
FDA Intel has 4 Form 483s on file for Hybrid Pharma LLC; the most recent is dated Nov 9, 2023.
When was Hybrid Pharma LLC last inspected by FDA?
The most recent FDA inspection document on file for Hybrid Pharma LLC is a Form 483 dated Nov 9, 2023, for the site in Deerfield Beach, Florida.
What did FDA cite at Hybrid Pharma LLC?
The regulations cited most in the observations on file for Hybrid Pharma LLC are 21 CFR 211.42(c)(10)(i) (Design and construction features), 10 times; 21 CFR 211.165(a) (Testing and release for distribution), 4 times; 21 CFR 211.113(b) (Control of microbiological contamination), 3 times.
Has Hybrid Pharma LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hybrid Pharma LLC; the most recent is dated Jun 7, 2022.