Reynolds Engineering and Equipment, Inc.
Form 483 issued January 11, 2024 · Muscatine, Iowa
- Observations
- 5
- Pages
- 8
- FEI number
- 3010551060
In short: On January 11, 2024, FDA issued a Form 483 with 5 observations to Reynolds Engineering and Equipment, Inc. in Muscatine, Iowa (FEI 3010551060). Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is no written testing program designed to assess the stability…
- 03
The identity of each component of a drug product is not verified by conducting at least…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Questions about this 483
What did FDA find at Reynolds Engineering and Equipment, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
When was Reynolds Engineering and Equipment, Inc. inspected by FDA?
This Form 483 is dated January 11, 2024.
How do I get the full Form 483 for Reynolds Engineering and Equipment, Inc.?
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.