Cambridge Isotope Laboratories, Inc.
FDA inspection history in Andover, Massachusetts, 2016 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Andover, Massachusetts.
- 2016The longest 483 on file: 3 observations over 2 pages at Andover, Massachusetts.
- 2022One Form 483, at Andover, Massachusetts.
Cited most
Across all Cambridge Isotope Laboratories observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Cambridge Isotope Laboratories file.
All 2 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
Andover, Massachusetts
Two Form 483s · 2016 to 2022 · 4 observations
Latest: Form 483, Aug 30, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-08-30 | 483 Form 483 | Andover, Massachusetts | 1 | $99 |
| 2016-03-25 | 483 Form 483 | Andover, Massachusetts | 3 | $99 |
Investigators on these documents
FEI number 1000513287 · most recent document Aug 30, 2022
About Cambridge Isotope Laboratories, Inc.
How many FDA Form 483s has Cambridge Isotope Laboratories, Inc. received?
FDA Intel has 2 Form 483s on file for Cambridge Isotope Laboratories, Inc.; the most recent is dated Aug 30, 2022.
When was Cambridge Isotope Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Cambridge Isotope Laboratories, Inc. is a Form 483 dated Aug 30, 2022, for the site in Andover, Massachusetts.
What did FDA cite at Cambridge Isotope Laboratories, Inc.?
The regulations cited most in the observations on file for Cambridge Isotope Laboratories, Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.