Custom Research Labs Inc
FDA inspection history across 2 sites, 2016 to 2022
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2021: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Gardena, California.
- 2021–22One Form 483 and one warning letter, at GARDENA, California and Gardena, California.
- 2021The longest 483 on file: 10 observations over 10 pages at GARDENA, California.
Cited most
Across all Custom Research Labs observations on file
- 21 CFR 211.137(a)Expiration dating3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.180(b)General requirements2
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures2
The complete Custom Research Labs file.
All 3 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
Gardena, California
One warning letter and one Form 483 · 2016 to 2022 · 10 observations
Latest: Warning letter, Jul 8, 2022 →GARDENA, California
One Form 483 · 2021 · 10 observations
Latest: Form 483, Jun 4, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-08 | Warning letter Warning letter | Gardena, California | — | $99 |
| 2021-06-04 | 483 Form 483 | GARDENA, California | 10 | $99 |
| 2016-06-01 | 483 Form 483 | Gardena, California | 10 | $99 |
Investigators on these documents
Darren S. Brown (1)Dogbeda F. Mackenzie (1)Jeffrey P. Raimondi (1)
FEI number 3008268262 · most recent document Jul 8, 2022
About Custom Research Labs Inc
How many FDA Form 483s has Custom Research Labs Inc received?
FDA Intel has 2 Form 483s on file for Custom Research Labs Inc; the most recent is dated Jun 4, 2021.
When was Custom Research Labs Inc last inspected by FDA?
The most recent FDA inspection document on file for Custom Research Labs Inc is a Form 483 dated Jun 4, 2021, for the site in GARDENA, California.
What did FDA cite at Custom Research Labs Inc?
The regulations cited most in the observations on file for Custom Research Labs Inc are 21 CFR 211.137(a) (Expiration dating), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.160(a) (General requirements), 2 times.
Has Custom Research Labs Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Custom Research Labs Inc; the most recent is dated Jul 8, 2022.