Catalent Massachusetts, LLC
Form 483 issued November 30, 2021 · Chelsea, Massachusetts
- Inspection
- Nov 8 – Nov 30, 2021
- Investigators
- Daniel L. Zheng· Leanna M. Slarsky· Robert J. Martin
- Observations
- 4
- Pages
- 4
- FEI number
- 3011696115
In short: On November 30, 2021, FDA issued a Form 483 with 4 observations to Catalent Massachusetts, LLC in Chelsea, Massachusetts (FEI 3011696115) after an inspection that ran Nov 8 – Nov 30, 2021. The investigators were Daniel L. Zheng, Leanna M. Slarsky and Robert J. Martin. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCatalent Massachusetts, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Massachusetts, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and materials. The opening words of each observation are shown on this page.
Who inspected Catalent Massachusetts, LLC?
Daniel L. Zheng, Leanna M. Slarsky and Robert J. Martin are named on this Form 483, for the inspection of Nov 8 – Nov 30, 2021. Each investigator has a profile showing what they cite most.
When was Catalent Massachusetts, LLC inspected by FDA?
The inspection ran Nov 8 – Nov 30, 2021, and the Form 483 is dated November 30, 2021.
How do I get the full Form 483 for Catalent Massachusetts, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.