Blossom Pharmaceuticals
Form 483 issued April 11, 2025
- Inspection
- Apr 7 – Apr 11, 2025
- Investigator
- Kellia N. Hicks
- Observations
- 7
- Pages
- 14
- FEI number
- 3010806039
In short: On April 11, 2025, FDA issued a Form 483 with 7 observations to Blossom Pharmaceuticals (FEI 3010806039) after an inspection that ran Apr 7 – Apr 11, 2025. The investigator was Kellia N. Hicks. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production and process…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmBlossom Pharmaceuticals history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blossom Pharmaceuticals?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Blossom Pharmaceuticals?
Kellia N. Hicks is named on this Form 483, for the inspection of Apr 7 – Apr 11, 2025. Each investigator has a profile showing what they cite most.
When was Blossom Pharmaceuticals inspected by FDA?
The inspection ran Apr 7 – Apr 11, 2025, and the Form 483 is dated April 11, 2025.
How do I get the full Form 483 for Blossom Pharmaceuticals?
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.