Spray-Tek, Inc.
Form 483 issued August 17, 2022 · Bethlehem, Pennsylvania
- Inspection
- Aug 8 – Aug 17, 2022
- Investigator
- Michele Gottshall
- Observations
- 2
- Pages
- 3
- FEI number
- 3003093165
In short: On August 17, 2022, FDA issued a Form 483 with 2 observations to Spray-Tek, Inc. in Bethlehem, Pennsylvania (FEI 3003093165) after an inspection that ran Aug 8 – Aug 17, 2022. The investigator was Michele Gottshall. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to identify potential root causes and corrective actions during…
- 02
Your firm did not conduct a product impact risk assessment as a result of these EM…
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmSpray-Tek, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spray-Tek, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Spray-Tek, Inc.?
Michele Gottshall is named on this Form 483, for the inspection of Aug 8 – Aug 17, 2022. Each investigator has a profile showing what they cite most.
When was Spray-Tek, Inc. inspected by FDA?
The inspection ran Aug 8 – Aug 17, 2022, and the Form 483 is dated August 17, 2022.
How do I get the full Form 483 for Spray-Tek, 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.