Hayward Laboratories, Inc.
Form 483 issued July 20, 2017 · E Stroudsburg, Pennsylvania
- Inspection
- Jun 28 – Jul 20, 2017
- Investigator
- James M. Mason
- Observations
- 9
- Pages
- 12
- FEI number
- 2220345
In short: On July 20, 2017, FDA issued a Form 483 with 9 observations to Hayward Laboratories, Inc. in E Stroudsburg, Pennsylvania (FEI 2220345) after an inspection that ran Jun 28 – Jul 20, 2017. The investigator was James M. Mason. Most observations concern facilities & equipment and production.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 04
The accuracy, sensitivity, specificity and reproducibility of test methods…
This inspection in context
James M. Mason
13 documents · 2011–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmHayward Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hayward Laboratories, Inc.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Hayward Laboratories, Inc.?
James M. Mason is named on this Form 483, for the inspection of Jun 28 – Jul 20, 2017. Each investigator has a profile showing what they cite most.
When was Hayward Laboratories, Inc. inspected by FDA?
The inspection ran Jun 28 – Jul 20, 2017, and the Form 483 is dated July 20, 2017.
How do I get the full Form 483 for Hayward Laboratories, 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.