American Specialty Pharmacy
Overview
American Specialty Pharmacy is a pharmaceutical company headquartered in Farmers Branch, United States, founded in 2010, with 201-500 employees.
FDA compliance signals
22 FDA enforcement records linked to this company.
- warning_letter2017-04-04
FDA Warning Letter (drug product)
- warning_letter2016-06-28
FDA Warning Letter (drug product)
- 4832015-08-05
Cleaning System
- 4832015-08-05
Protective Apparel Not Worn
- 4832015-08-05
Environmental Monitoring System
- 4832015-08-05
Training--operations, GMPs, written procedures
- 4832015-08-05
Protection from external factors
- 4832015-08-05
Solution clarity, completeness, pH
- 4832015-08-05
Procedures for sterile drug products
- 4832015-08-05
Aseptic Processing Area
- 4832015-08-05
No written record of investigation
- 4832015-08-05
Calibration/Inspection/Checking not done
- recall — Class II2015-04-01
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
- 4832014-12-19
Lack of written stability program
- 4832014-12-19
Equipment to control conditions
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