Catbird
Senior Moderator
FDA: Update on Main Street Family Pharmacy Products (edited)
[6/12/2013]
Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the Main Street Family Pharmacy (Main Street). An FDA Form 483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final Agency determination of whether any condition is in violation of the Federal Food, Drug and Cosmetic Act (FFDCA) or any of our relevant regulations but the observations often serve as evidence of a violation of the FFDCA and its implementing regulations.
FDA Form 483 (PDF - 873KB)
[6/13/2013]
Samples of injectable methylprednisolone acetate test positive for microbial contamination
As part of the ongoing FDA investigation of Main Street Family Pharmacy (Main Street) of Newbern, TN, FDA has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials. The microbial growth was seen in samples from two separate lots (batches). FDA and CDC laboratories, working together, provide the following preliminary microbial identification results:
Medication: PF MPA 80 mg/mL ? 10 mL per vial
Lot Number: 011413dan
Preliminary Microbial Identification : Bacillus pumilus, Bacillus cereus/thuringiensis/mycoides*, Roseomonas gilardii, Acinetobacter ursingii, Alternaria sp., Cladosporium sp.
Medication: PF MPA 80 mg/mL ? 10 mL per vial
Lot Number: 010913dan
Preliminary Microbial Identification : Bacillus licheniformis, Penicillium sp.
(*) unable to distinguish which species at this time
Additional samples and lots of PF MPA are still under evaluation, as well as other sterile products produced by Main Street. We will share additional information as it becomes available.
[6/12/2013]
Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the Main Street Family Pharmacy (Main Street). An FDA Form 483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final Agency determination of whether any condition is in violation of the Federal Food, Drug and Cosmetic Act (FFDCA) or any of our relevant regulations but the observations often serve as evidence of a violation of the FFDCA and its implementing regulations.
FDA Form 483 (PDF - 873KB)
[6/13/2013]
Samples of injectable methylprednisolone acetate test positive for microbial contamination
As part of the ongoing FDA investigation of Main Street Family Pharmacy (Main Street) of Newbern, TN, FDA has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials. The microbial growth was seen in samples from two separate lots (batches). FDA and CDC laboratories, working together, provide the following preliminary microbial identification results:
Medication: PF MPA 80 mg/mL ? 10 mL per vial
Lot Number: 011413dan
Preliminary Microbial Identification : Bacillus pumilus, Bacillus cereus/thuringiensis/mycoides*, Roseomonas gilardii, Acinetobacter ursingii, Alternaria sp., Cladosporium sp.
Medication: PF MPA 80 mg/mL ? 10 mL per vial
Lot Number: 010913dan
Preliminary Microbial Identification : Bacillus licheniformis, Penicillium sp.
(*) unable to distinguish which species at this time
Additional samples and lots of PF MPA are still under evaluation, as well as other sterile products produced by Main Street. We will share additional information as it becomes available.