Cambridge Isotope Laboratories, Inc.
FDA inspection history in Tewksbury, Massachusetts, 2017 to 2020
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Tewksbury, Massachusetts.
- 2017The longest 483 on file: 4 observations over 7 pages at Tewksbury, Massachusetts.
- 2020One Form 483, at Tewksbury, Massachusetts.
Cited most
Across all Cambridge Isotope Laboratories observations on file
- 21 CFR 212.40(a)How must I control the components I use to produce PET drugs and the containers and closures I package them in?2
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
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
Tewksbury, Massachusetts
Two Form 483s · 2017 to 2020 · 8 observations
Latest: Form 483, Dec 9, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-12-09 | 483 Form 483 | Tewksbury, Massachusetts | 4 | $99 |
| 2017-05-01 | 483 Form 483 | Tewksbury, Massachusetts | 4 | $99 |
Investigators on these documents
John P. Mistler (1)Robert J. Martin (1)Sean R. Marcsisin (1)
FEI number 3010827078 · most recent document Dec 9, 2020
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 Dec 9, 2020.
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 Dec 9, 2020, for the site in Tewksbury, 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 212.40(a) (How must I control the components I use to produce PET drugs and the containers and closures I package them in?), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.