Blaine Labs Inc.
FDA inspection history in Santa Fe Springs, California, 2019 to 2023
- 3
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one Form 483; 2020: one close-out letter; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Three Form 483s and one close-out letter, at Santa Fe Springs, California.
- 2019The longest 483 on file: 13 observations over 10 pages at Santa Fe Springs, California.
Cited most
Across all Blaine Labs observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.63Equipment design, size, and location3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
The complete Blaine Labs file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Santa Fe Springs, California
Three Form 483s and one close-out letter · 2019 to 2023 · 29 observations
Latest: Form 483, Dec 15, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-15 | 483 Form 483 | Santa Fe Springs, California | 4 | $99 |
| 2021-08-24 | 483 Form 483 | Santa Fe Springs, California | 12 | $99 |
| 2020-05-05 | Close-out Close-out letter | Santa Fe Springs, California | — | $99 |
| 2019-09-30 | 483 Form 483 | Santa Fe Springs, California | 13 | $99 |
Investigators on these documents
FEI number 3001744192 · most recent document Dec 15, 2023
About Blaine Labs Inc.
How many FDA Form 483s has Blaine Labs Inc. received?
FDA Intel has 3 Form 483s on file for Blaine Labs Inc.; the most recent is dated Dec 15, 2023.
When was Blaine Labs Inc. last inspected by FDA?
The most recent FDA inspection document on file for Blaine Labs Inc. is a Form 483 dated Dec 15, 2023, for the site in Santa Fe Springs, California.
What did FDA cite at Blaine Labs Inc.?
The regulations cited most in the observations on file for Blaine Labs Inc. are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 211.63 (Equipment design, size, and location), 3 times.